Role of Topical Steroid Injection With Refractory Benign Esophageal Stricture Endoscopic Dilatation in Children (ISIs)

This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Diseases; Pediatric Disorder; Esophageal Stricture
• Intervention / Treatment: Procedure: Esophageal dilatation with steroids injection

Detailed Description

Background and study aims: Benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. This study investigates the efficacy and safety of intralesional steroid injections (ISIs) in addition to dilation in patients with refractory benign esophageal strictures.

Methods: This clinical trial study included 21 children with refractory benign esophageal strictures. Upper GI endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. The effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (PDI) and dysphagia score.

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad Daboos; Phone Number: 01007578148; Email: daboosmohammad@gmail.com

Study Locations

• Egypt
  • Select
    • Cairo, Select, Egypt, 115678
      • Recruiting
      • Mohammad Daboos
      • Contact: Mohammad Daboos; Phone Number: 01007578148; Email: daboosmohammad@gmail.com
      • Contact: Email: daboosmohammad@gmail.com
      • Principal Investigator: Mohammad Daboos, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients aged less than 14 years
• with refractory benign esophageal strictures
• received a dilatation therapy without triamcinolone injections

Exclusion Criteria:

• failure to pass a guide wire secondary to pharyngeal stenosis
• tracheo-esophageal fistula
• those who received triamcinolone injections at early dilatation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: refractory benign esophageal strictures patients; Pediatric patients aged less than 14 years, with refractory benign esophageal strictures and received a dilatation therapy without triamcinolone injections

Procedure: Esophageal dilatation with steroids injection; Under general anesthesia with the patient in the left lateral position. A single-channel endoscope was used. Endoscopic bougie dilatation was performed using Wire-guided Polyvinyl dilator Savary Gilliard/SG. Long-acting steroids triamcinolone acetonide was injected via 25-gauge sclerotherapy catheter. One mL solution of triamcinolone acetonide 40mg/ml was diluted with one mL of saline, in a 2 mL disposable syringe, and 0.5 mL each was injected at the proximal margin of the stricture in four quadrants, 2 mL solution in four quadrants; Other Names: ISIs Endoscopic dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum dilatation size	achieving a diameter of 11 mm for patients aged <2 years, 12 mm for patients aged between 2 and 5 years, and 15 mm for children aged >5 years with complete relief of symptoms without requiring endoscopic procedure or surgical intervention for at least 6 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dysphagia score	Dysphagia was graded into the following: Score 0 - No dysphagia: able to eat a normal diet.; Score 1 - Moderate passage: able to eat some solid foods.; Score 2 - Poor passage: able to eat only semi-solid foods.; Score 3 - Very poor passage: able to swallow only liquids only.; Score 4 - No passage: unable to swallow anything	12 months

Collaborators and Investigators

• Sponsor: Mohammad Daboos
• Investigators: Principal Investigator: Mohammad Daboos, Department of pediatric surgery, faculty of medicine , Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 20, 2024

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 22, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Steroid injection; Esophageal stricture; Esophageal dilatation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Dilatation, Pathologic; Esophageal Diseases; Esophageal Stenosis
• Other Study ID Numbers: 00012367-24-06-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No